Differential diagnosis method for diagnosing prostate carcinoma cases

FIELD: medicine.

SUBSTANCE: method involves carrying out differential diagnosis study for determining prostate tumor type. Transrectal ultrasonic examination is carried out and prostate-specific antigen density is determined in patient blood serum. Free fraction density of the prostate-specific antigen being below 0.04 ng/ml per 1 cm3, and general prostate-specific antigen concentration being equal to 0-20 ng/ml, malignant tumor is to be diagnosed. General prostate-specific antigen concentration being higher than 20 ng/ml, malignant tumor is to be diagnosed.

EFFECT: high diagnosis accuracy.

 

The invention relates to medicine, namely to oncourology, in particular to methods of diagnosis of malignant tumors of the prostate gland and can be used to improve the efficiency differential diagnosis of prostate cancer.

The closest in technical essence and the achieved result is a method of differential diagnosis of malignant and benign tumors of the prostate using transrectal ultrasound transrectal us) and determination of total serum prostatespecific antigen (t-PSA). Patients with ultrasound characteristics of a malignant process, is needle biopsy. Parallel to the examined individuals is determined by the level of t-DOG. The concentration of t-PSA 4 ng/ml is discriminatory, above which indicates a high risk of developing prostate cancer. Persons with t-PSA above 4 ng/ml is also shown biopsy (Schal-Shukri, Vneck. Tumors of the urinary organs. S.-Petersburg, 2000, - S-278).

The disadvantage of this method is the presence of a number of patients with concomitant diseases of the prostate, which masks pathognomonic ultrasound criteria of malignancy of the tumor of the prostate gland, which is accompanied by cases of cancer passes due to the lack of character who's signs of malignancy during transrectal us. On the other hand, benign prostate tumors can be ultrasonic characteristics that mimic cancer, as a result are unnecessary biopsy. T-PSA above 4 ng/ml have about 40% of men with benign prostate disease, i.e. a high percentage of false positive in relation to prostate cancer results. At the same time in 18% of patients with prostate cancer t-PSA below 4 ng/ml, they do not carry out a biopsy and do not reveal prostate cancer.

The technical result, which directed the establishment of this invention is to increase the efficiency of differential diagnosis, leading to reduction in the number of unnecessary and increase the number of biopsies and reduce the number of passes prostate cancer.

The technical result is achieved in that in the method of differential diagnosis of malignant tumors of the prostate, which consists in conducting transrectal ultrasound examination and determination of serum prostatespecific antigen, further define the content density of the free fraction prostatespecific antigen in the blood of the patient, while the content of the density of the free fraction prostatespecific antigen is less than 0.04 ng/ml 1 CC, and the level of total prostatespecific EN the Egan from 0 to 20 ng/ml indicate a benign tumor, and the content of the density of the free fraction prostatespecific antigen higher than 0.04 ng/ml 1 CC, and the level of total prostatespecific antigen from 0 to 20 ng/ml indicate malignant, the level of total prostatespecific antigen above 20 ng/ml indicates a malignant tumor.

Implement the method as follows: before or after transrectal ultrasound take blood from the cubital vein in one tube. The resulting material is examined for the content of serum t-PSA and define the content of the free fraction of serum PSA enzyme-linked immunosorbent assay. During transrectal ultrasound determine prostate volume according to the standard formula.

After a blood test determine the content density of the free fraction of PSA, which divide its concentration in the peripheral blood on the volume of the prostate and produce evidence needle biopsy of the prostate transrectal access, in keeping with the rules of asepsis and antisepsis, under ultrasound control. The resulting material examined histologically.

Malignant tumors in individuals with the contents of the level of total PSA from 0.1 to 20 ng/ml are accompanied by density level of free fractions of PSA above 0.04 ng/ml 1 CC, and benign - level density is STI free fraction PSA < 0.04 ng/ml in 1 scooter

Examples

1. Patient A., 70, referring diagnosis: prostate cancer, the level of t-PSA - 2.3 ng/ml, the content of the level density of the free fraction of PSA - 0.05 ng/ml 1 CC, there are ultrasonic changes suspicious for cancer. Made sighting needle biopsy under ultrasound. The histological conclusion: moderately differentiated melkoatsinarnaya adenocarcinoma.

2. Patient T., aged 63, referring diagnosis: prostate adenoma. Conclusion ultrasound: ultrasound signs of chronic prostatitis, the suspicion of organic disease of the prostate gland. T-DOG to 11.8 ng/ml, the density level of free fractions of PSA 0.06 ng/ml at 1 scooter biopsy Performed under ultrasound. The histological conclusion: melkoatsinarnaya adenocarcinoma.

3. Patient S., aged 65, referring diagnosis: benign prostatic hyperplasia. Performed transrectal ultrasound examination, determination of the level of total PSA and the content of the level density of the free fraction DOG. Conclusion ultrasound: benign prostatic hyperplasia. The level of total PSA of 6.8 ng/ml, the content of the level density of the free fraction of PSA - 0.02 ng/ml in 1 scooter biopsy Performed under ultrasound. The histological conclusion: a mixed form nodoz the Oh prostate hyperplasia.

4. Patient P., 60, referring diagnosis: prostate adenoma. Performed transrectal ultrasound, determined the level of t-DOG and the content of the level density of the free fraction of PCA. Conclusion ultrasound: adenoma of the prostate gland on the background of chronic prostatitis, the suspicion of organic disease. T-DOG to 14.9 ng/ml, the content of the level density of the free fraction of PSA - 0.02 ng/ml per 1 cubic cm biopsy Performed under ultrasound. Cytological conclusion: mixed hyperplasia.

Spent an analysis of the prior art, including searching by the patent and scientific and technical information sources and identify sources that contain information about the equivalents of the claimed invention, has allowed to establish that the petitioners have not found a similar, characterized by signs, identical to all the essential features of the claimed invention.

The definition of a list of the closest analogues of the technical solution (prototype) has identified a set of essential in relation to perceived technical result of the distinctive features in the claimed method of differential diagnosis set forth in the claims.

Therefore, the claimed invention meets the criterion of "novelty".

To ensure the key compliance of the claimed invention, the criterion of "inventive step" applicants conducted an additional search of the known solutions to identify signs that match the distinctive features of the prototype of the features of the proposed method for differential diagnosis.

The search results showed that the claimed invention is not apparent to the expert in the obvious way from the prior art, certain applicants.

Therefore, the claimed invention meets the criterion of "inventive step".

The criterion "industrial applicability" is confirmed by the fact that the proposed method of differential diagnosis can be effectively, efficiently and used in diagnostic centers, Oncology and urologic clinics of Russia and the CIS.

The method of differential diagnosis of tumors of the prostate gland, which consists in conducting transrectal ultrasound examination and determination of serum prostatespecific antigen, characterized in that it further determine the content density of the free fraction prostatespecific antigen in the blood of the patient, while the content of the density of the free fraction prostatespecific antigen below 0.04 ng/ml on 1 cm3and at the level of General prostatespecific antigen from 0 to 20 ng/ml indicates a benign tumor, and the content of the density of the free fraction prostatespecific antigen in the above 0.04 ng/ml on 1 cm 3and at the level of General prostatespecific antigen from 0 to 20 ng/ml indicates a malignant, and the level of total prostatespecific antigen above 20 ng/ml indicates a malignant tumor.



 

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